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The Effect of Fish-oil Lipid Emulsions on Neonatal Cholestasis and Retinopathy of Prematurity
Docosahexaenoic acid (DHA) has been shown to be particularly important for fetal and neonatal development. Infants born prematurely are at special risk for DHA insufficiency. The source of DHA after birth for preterm babies who are not fed full enterally, are mostly fat emulsions as the component of total parenteral nutrition solutions which usually do not contain DHA. The aim of this study is to investigate if the fish oil emulsion-administered from the first day of life and during parenteral nutrition-prevents infants from cholestasis and retinopathy of prematurity.
During the study period, preterm infants admitted to NICU were included. Infants who weighed \<1500 gr and delivered prematurely before the 32nd week of gestation were eligible for the study. Infants with major congenital anomalies, congenital infections and inborn metabolic errors were excluded from the study. Group 1: Fish-oil emulsion (20% SMOFLipid: soybean oil 60 g/dL, MCT 60 g/dL, olive oil 50 g/dL, fish oil 30 g/dL, egg phospholipids 12 g/dL, glycerol 25 g/dL, vitamin E 200 mg α-TE/L) Group 2: Soybean oil emulsion (20% Intralipid: soybean oil 200 g/dL, egg phospholipids 12 g/dL, glycerol 22,5 g/dL, vitamin E 57 mg α-TE/L).
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
No
Dr. Sami Ulus Childrens Hospital
Ankara, Turkey (Türkiye)
Start Date
January 1, 2013
Primary Completion Date
September 1, 2013
Completion Date
November 1, 2013
Last Updated
July 8, 2014
80
ACTUAL participants
Fish-oil emulsions
DIETARY_SUPPLEMENT
soybean-oil emulsion
DIETARY_SUPPLEMENT
Lead Sponsor
Dr. Sami Ulus Children's Hospital
NCT06315556
NCT06067958
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